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New treatment option for Colorectal Cancer
Official title Protein Needs Study
ClinicalTrials.gov ID: NCT04144907
What this study is testing
- What it's testing
- Severe muscle loss in patients with cancer has been associated with increased physical disability, extended hospitalization, infectious and noninfectious complications, increased risk of severe toxicity during cancer treatment, poor quality of life and shortened survival. Adequate protein is key to sustain muscle mass and overall health.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 80
You may be able to join if
- Outpatients age 45-80 years;
- Patients attending the new patient clinic at the Cross Cancer Institute with a diagnosis of colorectal cancer or breast cancer (stages II to III);
- Able to complete baseline visits within approximately 4 weeks of starting chemotherapy OR after a minimum of 4 weeks post-surgery if not undergoing...
- Ambulatory.
You likely can't join if
- Premenopausal women due to impact on protein requirements;
- Received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit;
- Renal impairment based on a creatinine clearance for estimated glomerular filtration rate (eGFR) of \<60 mL/min
- Abnormal glucose metabolism based on a fasting glucose level \>6mmol/L and an HbA1c \>5.7% or as reviewed by study team;
- Comorbidities or medications that would interfere with the participants ability to follow the study protocol or the quality of the data(e.g...
- Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.);
See the full eligibility criteria
- Outpatients age 45-80 years;
- Patients attending the new patient clinic at the Cross Cancer Institute with a diagnosis of colorectal cancer or breast cancer (stages II to III);
- Able to complete baseline visits within approximately 4 weeks of starting chemotherapy OR after a minimum of 4 weeks post-surgery if not undergoing chemotherapy;
- Ambulatory.
- Premenopausal women due to impact on protein requirements;
- Received anti-cancer hormone treatment or immunotherapy in the 4 weeks before first baseline visit;
- Renal impairment based on a creatinine clearance for estimated glomerular filtration rate (eGFR) of \<60 mL/min
- Abnormal glucose metabolism based on a fasting glucose level \>6mmol/L and an HbA1c \>5.7% or as reviewed by study team;
- Comorbidities or medications that would interfere with the participants ability to follow the study protocol or the quality of the data(e.g. diabetes, class III obesity, hormone therapy, another active cancer diagnosis);
- Unable/unwilling to provide urine, breath and blood samples (e.g. oxygen tank, catheter, etc.);
- Unable to eat the meals provided (i.e. receiving parenteral or enteral nutrition, severe allergies);
- Substance dependent (e.g. alcohol, cigarettes, illicit drugs) and unable to follow study protocols.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.